Nuvaxovid · 4.4 Special warnings and precautions for use · 4

HOS-100099 · has-adverse-reaction-information · PDF-Seite 40

Nuvaxovid (Original, Wuhan strain) Summary of the safety profile after primary series Participants 18 years of age and older The most frequent adverse reactions after administration of a Nuvaxovid dose within the primary series were injection site tenderness (75%), injection site pain (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (14%). Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. Overall, there was a higher incidence of adverse reactions in younger age groups: in adults aged 18 to less than 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Following co-administration with seasonal influenza vaccine, higher frequencies of local adverse reactions at the Nuvaxovid injection site (70% after Dose 1 and 85% after Dose 2) and systemic adverse reactions (60% after Dose 1 and 70% after Dose 2) have been observed. Adolescents 12 through 17 years of age The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Fever was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 3 days for local and systemic events following vaccination. Summary of the safety profile after booster dose Participants 18 years of age and older The most frequent adverse reactions reported following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (73%), injection site pain (61%), fatigue (53%), muscle pain (52%), headache (46%), malaise (41%), and joint pain (26%). Adolescents 12 through 17 years of age The most frequent solicited adverse reactions following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (66%), injection site pain (65%), headache (63%), muscle pain (60%), fatigue (57%), malaise (45%), and nausea/vomiting (23%) with a median duration of 2 to 3 days following vaccin

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100093 · has-adverse-reaction-information · PDF-Seite 22

Nuvaxovid (Original, Wuhan strain) Summary of the safety profile after primary series Participants 18 years of age and older The most frequent adverse reactions after administration of a Nuvaxovid dose within the primary series were injection site tenderness (75%), injection site pain (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (14%). Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. Overall, there was a higher incidence of adverse reactions in younger age groups: in adults aged 18 to less than 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Following co-administration with seasonal influenza vaccine, higher frequencies of local adverse reactions at the Nuvaxovid injection site (70% after Dose 1 and 85% after Dose 2) and systemic adverse reactions (60% after Dose 1 and 70% after Dose 2) have been observed. Adolescents 12 through 17 years of age The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Fever was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 3 days for local and systemic events following vaccination. Summary of the safety profile after booster dose Participants 18 years of age and older The most frequent adverse reactions reported following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (73%), injection site pain (61%), fatigue (53%), muscle pain (52%), headache (46%), malaise (41%), and joint pain (26%). Adolescents 12 through 17 years of age The most frequent solicited adverse reactions following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (66%), injection site pain (65%), headache (63%), muscle pain (60%), fatigue (57%), , malaise (45%), and nausea/vomiting (23%) with a median duration of 2 to 3 days following vac

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100087 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile after primary series Participants 18 years of age and older The most frequent adverse reactions after administration of a Nuvaxovid dose within the primary series were injection site tenderness (75%), injection site pain (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (14%). Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. Overall, there was a higher incidence of adverse reactions in younger age groups: in adults aged 18 to less than 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Following co-administration with seasonal influenza vaccine, higher frequencies of local adverse reactions at the Nuvaxovid injection site (70% after Dose 1 and 85% after Dose 2) and systemic adverse reactions (60% after Dose 1 and 70% after Dose 2) have been observed. Adolescents 12 through 17 years of age The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Fever was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 3 days for local and systemic events following vaccination. Summary of the safety profile after booster dose Participants 18 years of age and older The most frequent adverse reactions reported following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (73%), injection site pain (61%), fatigue (53%), muscle pain (52%), headache (46%), malaise (41%), and joint pain (26%). Adolescents 12 through 17 years of age The most frequent solicited adverse reactions following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (66%), injection site pain (65%), headache (63%), muscle pain (60%), fatigue (57%), malaise (45%), and nausea/vomiting (23%) with a median duration of 2 to 3 days following vaccination. Tabulated list of adverse

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100111 · has-adverse-reaction-information · PDF-Seite 73

Nuvaxovid (Original, Wuhan strain) Summary of the safety profile after primary series Participants 18 years of age and older The most frequent adverse reactions after administration of a Nuvaxovid dose within the primary series were injection site tenderness (75%), injection site pain (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (14%). Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. Overall, there was a higher incidence of adverse reactions in younger age groups: in adults aged 18 to less than 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Following co-administration with seasonal influenza vaccine, higher frequencies of local adverse reactions at the Nuvaxovid injection site (70% after Dose 1 and 85% after Dose 2) and systemic adverse reactions (60% after Dose 1 and 70% after Dose 2) have been observed. Adolescents 12 through 17 years of age The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Fever was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 3 days for local and systemic events following vaccination. Summary of the safety profile after booster dose Participants 18 years of age and older The most frequent adverse reactions reported following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (73%), injection site pain (61%), fatigue (53%), muscle pain (52%), headache (46%), malaise (41%), and joint pain (26%). Adolescents 12 through 17 years of age The most frequent solicited adverse reactions following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (66%), injection site pain (65%), headache (63%), muscle pain (60%), fatigue (57%), malaise (45%), and nausea/vomiting (23%) with a median duration of 2 to 3 days following vaccin

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100105 · has-adverse-reaction-information · PDF-Seite 56

Nuvaxovid (Original, Wuhan strain) Summary of the safety profile after primary series Participants 18 years of age and older 56 The most frequent adverse reactions after administration of a Nuvaxovid dose within the primary series were injection site tenderness (75%), injection site pain (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (14%). Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. Overall, there was a higher incidence of adverse reactions in younger age groups: in adults aged 18 to less than 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Following co-administration with seasonal influenza vaccine, higher frequencies of local adverse reactions at the Nuvaxovid injection site (70% after Dose 1 and 85% after Dose 2) and systemic adverse reactions (60% after Dose 1 and 70% after Dose 2) have been observed. Adolescents 12 through 17 years of age The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Fever was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 3 days for local and systemic events following vaccination. Summary of the safety profile after booster dose Participants 18 years of age and older The most frequent adverse reactions reported following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (73%), injection site pain (61%), fatigue (53%), muscle pain (52%), headache (46%), malaise (41%), and joint pain (26%). Adolescents 12 through 17 years of age The most frequent solicited adverse reactions following receipt of a booster dose of Nuvaxovid after the two-dose primary series were injection site tenderness (66%), injection site pain (65%), headache (63%), muscle pain (60%), fatigue (57%), malaise (45%), and nausea/vomiting (23%

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100083 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100107 · has-contraindication-information · PDF-Seite 70

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100095 · has-contraindication-information · PDF-Seite 37

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100101 · has-contraindication-information · PDF-Seite 54

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100089 · has-contraindication-information · PDF-Seite 19

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100106 · has-indication-information · PDF-Seite 69

Nuvaxovid XFG is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. 69

HOS-100100 · has-indication-information · PDF-Seite 53

Nuvaxovid JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. 53

HOS-100082 · has-indication-information · PDF-Seite 2

Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. 2

HOS-100088 · has-indication-information · PDF-Seite 18

Nuvaxovid XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS- CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. 18

HOS-100094 · has-indication-information · PDF-Seite 36

Nuvaxovid JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. 36

HOS-100109 · has-interaction-information · PDF-Seite 72

Co-administration of Nuvaxovid (Original, Wuhan strain) with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. The clinical significance of this is unknown. Concomitant administration of Nuvaxovid XFG with other vaccines has not been studied.

HOS-100085 · has-interaction-information · PDF-Seite 5

Co-administration of Nuvaxovid with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. The clinical significance of this is unknown. Concomitant administration of Nuvaxovid with other vaccines has not been studied.

HOS-100103 · has-interaction-information · PDF-Seite 56

Co-administration of Nuvaxovid (Original, Wuhan strain) with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. The clinical significance of this is unknown. Concomitant administration of Nuvaxovid JN.1 with other vaccines has not been studied.

HOS-100097 · has-interaction-information · PDF-Seite 39

Co-administration of Nuvaxovid (Original, Wuhan strain) with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. The clinical significance of this is unknown. Concomitant administration of Nuvaxovid JN.1 with other vaccines has not been studied.

HOS-100091 · has-interaction-information · PDF-Seite 21

Co-administration of Nuvaxovid (Original, Wuhan strain) with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. The clinical significance of this is unknown. Concomitant administration of Nuvaxovid XBB.1.5 with other vaccines has not been studied.

HOS-100092 · has-pregnancy-information · PDF-Seite 21

Pregnancy There is limited experience with use of Nuvaxovid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition, or post-natal development, see section 5.3. Administration of Nuvaxovid XBB.1.5 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. Breast-feeding It is unknown whether Nuvaxovid XBB.1.5 is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to Nuvaxovid XBB.1.5 is negligible. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100086 · has-pregnancy-information · PDF-Seite 5

Pregnancy There is limited experience with use of Nuvaxovid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition, or post-natal development, see section 5.3. Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. Breast-feeding It is unknown whether Nuvaxovid is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to Nuvaxovid is negligible. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100104 · has-pregnancy-information · PDF-Seite 56

Pregnancy There is limited experience with use of Nuvaxovid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition, or post-natal development, see section 5.3. Administration of Nuvaxovid JN.1 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. Breast-feeding It is unknown whether Nuvaxovid JN.1 is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to Nuvaxovid JN.1 is negligible. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100098 · has-pregnancy-information · PDF-Seite 39

Pregnancy There is limited experience with use of Nuvaxovid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition, or post-natal development, see section 5.3. Administration of Nuvaxovid JN.1 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. Breast-feeding It is unknown whether Nuvaxovid JN.1 is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to Nuvaxovid JN.1 is negligible. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100110 · has-pregnancy-information · PDF-Seite 72

Pregnancy There is limited experience with use of Nuvaxovid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition, or post-natal development, see section 5.3. Administration of Nuvaxovid XFG in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. Breast-feeding It is unknown whether Nuvaxovid XFG is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to Nuvaxovid XFG is negligible. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100084 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 3 General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported with Nuvaxovid. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. An additional dose of the vaccine should not be given to those who have experienced anaphylaxis to a prior dose of Nuvaxovid. Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days, see section 4.8. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. Imm

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100102 · has-warning-information · PDF-Seite 54

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported with Nuvaxovid. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. An additional dose of the vaccine should not be given to those who have experienced anaphylaxis to a prior dose of Nuvaxovid. 54 Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days, see section 4.8. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. Im

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100108 · has-warning-information · PDF-Seite 70

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported with Nuvaxovid. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. An additional dose of the vaccine should not be given to those who have experienced anaphylaxis to a prior dose of Nuvaxovid. 70 Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days, see section 4.8. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. Im

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100090 · has-warning-information · PDF-Seite 19

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported with Nuvaxovid. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. 19 Close observation for at least 15 minutes is recommended following vaccination. An additional dose of the vaccine should not be given to those who have experienced anaphylaxis to a prior dose of Nuvaxovid. Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days, see section 4.8. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100096 · has-warning-information · PDF-Seite 37

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported with Nuvaxovid. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. 37 Close observation for at least 15 minutes is recommended following vaccination. An additional dose of the vaccine should not be given to those who have experienced anaphylaxis to a prior dose of Nuvaxovid. Myocarditis and pericarditis There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days, see section 4.8. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

Auszug; vollständigen Abschnitt im Original lesen.